Clinical Operations Lead

About this role

Job Title: Clinical Operations Lead Job Location: Reading, Berkshire, United Kingdom Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to manage clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.

The Clinical Operations Lead supports the Clinical Trial Operational team in execution of the trials. The position maintains effective communication with project team through correspondence and status reports to ensure alignment with study timelines. The COL includes direct liaison with CROs and other vendors to manage relevant trial operational lasts. Main Responsibilities Assist in the review, development and writing of clinical trial documents and manuals, including but not limited to study manuals, laboratory or biomarker plans.

Create Master ICF template and review site changes. Update template for new risks and new amendments information. Participate in the feasibility and evaluation of investigative sites. Assist in the development and management of study timelines and priorities, including recruitment tools/ strategy and patient retentions plan. Plan and organize meetings with team support (eg. investigator/ coordinator meetings). Assist in the development of the IP and co-medication strategy.

Monitor study specific timelines and key deliverables; focus on management of vendors (eg. Monitoring, Sample management, IVRS, Laboratory). Develop relationships with investigational sites and institutions to enhance conduct of the trial. Acts as preliminary liaison for study sites to convey trial information, answer questions and in accordance with the escalation pathway. Required Skills and Qualifications Minimum of 3 years’ experience in the biopharmaceutical industry or other relevant clinical research experience.

Minimum 1 year or experience in Clinical Project Management. Proven work experience and knowledge of Oncology therapeutic area. Bachelor’s Degree or relevant degree with strong emphasis on Science. Prior experience in assisting the conduct and management of multinational/ global clinical trials. Strong experience in vendor management. Working knowledge of ICH Good Clinical Practices and other relevant regulatory experience.